BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1911825 · Received December 1, 2010

    Report

    Report Number
    2122870-2010-00826
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 3800 RPM FOR 10 MINUTES. BOTH LEVEL OF ACCUTNI QC WERE WITHIN THE CUSTOMERS ESTABLISHED RANGES PRE AND POST THE DAY OF THE EVENT. ON (B)(4) 2010, THE CUSTOMER PERFORMED ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) REMOVED, CLEANED, AND REASSEMBLED THE WASH VALVE. FSE PERFORMED VERIFICATION AS WELL AS ROUTINE AND HIGH SENSITIVITY SYSTEM CHECK. ALL TESTING PASSED WITHIN INSTRUMENT SPECIFICATIONS. FSE PERFORMED ASSAY QC AND NO ISSUES WERE NOTED. A CLEAR ROOT CAUSE CANNOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS ERRONEOUS HIGH ACCUTNI RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PATIENT GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE SAMPLE WAS REPEATED ON THE SAME AND AN ALTERNATE UNIT AND LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY SYSTEMS MMI BECKMAN COULTER INC. ACCESS 2 DXC600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR